ECG tracings

May I ask for your advice/comments please? The sponsor provided us (investigator site) a ECG machine of which ECG data is transferred electronically to the assigned company. At the same time, the machine prints the tracings to site for investigator to review.

- Do you consider if the transmissions are considered as the original source or the thermal paper tracings are.

- Because thermal paper is known to fade away over time, the sponsor requested site to make certified copies of ECG tracings. Could you advise if this is a standard procedure for ECG tracings?

I would like to update about our implementation on ECG tracings. Because QTC calculation is written on the tracings, they are source document. Therefore they have to be photocopied and certified. It is a lot of work and takes time to do this because different machines (provided by different sponsors) use different sizes of paper. Anyway, it has to be done.

To set up new studies, we encourage sponsors to provide the machine using non thermal paper. Some do but some don't because of the cost of the machine.